CANADIAN PHARMACEUTICAL FIRM Theratechnologies, which develops a HIV treatment drug, is building a team in Dublin to prepare for a European launch.
The Montreal-headquartered company’s main product is Trogarzo, an antiretroviral medicine, administered intravenously, that helps reduce a patient’s viral load – the measure of HIV in the body.
It hired Conor Walshe, who previously held senior roles at pharma firms Aralez and Perrigo in Ireland, as general manager earlier this year to oversee the European operations.
“The most important aspect of the role in the immediate future is to successfully navigate the variety of hurdles to bring our main product to market in Europe,” Walshe told Fora.
Theratechnologies is currently meandering through the various regulatory twists and turns in order to get its HIV drug on the market in Europe.
Trogarzo, which is in use in the US, is undergoing a review by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which carries out initial assessments.
The drug recently passed the latest step in that process by securing a recommendation from the Scientific Advisory Group, a body convened by the CHMP to examine HIV-related drugs.
This all leads to the last stage which is overall approval by the European Medicines Agency before Trogarzo can enter the EU market.
“The total lead time can be well over a year,” Walshe said.
According to the company, it chose Ireland to base these efforts for access to talent and a “stable political environment”.
Walshe said Theratechnologies’ office in Dublin will start small before growing to “numbers of note” in the next three to four years.
“It’s very competitive, what we’re looking for, we definitely have functional needs in the classic pharmaceutical area,” he said.
“We’ll be looking at functional needs on distribution and supply chain, on quality, on strong financial candidates and medical.”
“They are hard to find, they tend to be very competitive. We’re looking for very senior people who can lead this product through the myriad of the 28-plus European states that we’ll be launching the product in over time.”
Theratechnologies employs nearly 100 people in Canada and the US.
For the year ended November 2018, the company booked revenues of $58.5 million with sales of Trogarzo reaching $11.6 million in the year.